Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity

NCT ID: NCT04117347

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-24

Study Completion Date

2023-03-08

Brief Summary

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The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.

Detailed Description

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Brain emotional processing was determined with the Emotional Faces Assessment Task (EFAT). In this task, participants view a trio of faces and match one of the two faces (bottom) that expresses the same emotion as the target face (top). The faces display one of five expressions (angry, happy, fearful, sad, neutral) and the other (incongruent) probe face always displays a neutral (or happy if the target is neutral) expression. The paradigm consists of 20 face trials per expression and 20 shape trials, presented in pseudorandomized order, separated by a 3-7 sec intertrial blank screen with fixation cross.

Conditions

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Stress

Keywords

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Circadian timing Mood Light

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcomes assessor will be blinded to study arm. The PI, study coordinator and research assistants will remain unblinded to perform safety assessments and provide feedback on intervention adherence. Blinded staff will wear buttons as an upfront visual cue to remind participants not to talk about their treatment.

Study Groups

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Light therapy A via the Re-Timer®

-15 minutes/day

Group Type EXPERIMENTAL

Light therapy A via the Re-Timer®

Intervention Type DEVICE

Subjects will conduct light treatment in the mornings at home.

Light therapy B via the Re-Timer®

-30 minutes/day

Group Type EXPERIMENTAL

Light therapy B via the Re-Timer®

Intervention Type DEVICE

Subjects will conduct light treatment in the mornings at home.

Light therapy C via the Re-Timer®

-60 minutes/day

Group Type EXPERIMENTAL

Light therapy C via the Re-Timer®

Intervention Type DEVICE

Subjects will conduct light treatment in the mornings at home.

Interventions

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Light therapy A via the Re-Timer®

Subjects will conduct light treatment in the mornings at home.

Intervention Type DEVICE

Light therapy B via the Re-Timer®

Subjects will conduct light treatment in the mornings at home.

Intervention Type DEVICE

Light therapy C via the Re-Timer®

Subjects will conduct light treatment in the mornings at home.

Intervention Type DEVICE

Other Intervention Names

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Re-Timer® Re-Timer® Re-Timer®

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for traumatic stress
* Normal or corrected to normal vision
* Right-handed
* Fluency in English
* Physically able to travel for study visit attendance

Exclusion Criteria

* Significant chronic uncontrolled disease (e.g. uncontrolled diabetes, advanced liver disease, cancer, etc.)
* Severe hearing problem
* Intellectual disability or serious cognitive impairment
* Inability to tolerate enclosed spaces (e.g. the MRI machine)
* Ferrous-containing metals within the body
* Pregnant, trying to get pregnant, or breastfeeding
* Epilepsy
* Other research participation
* Frequent number of special events during study period (weddings, concerts, exams, etc.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Helen Burgess

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen Burgess

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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The University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Burgess HJ, Rizvydeen M, Huizenga B, Prasad M, Bahl S, Duval ER, Kim HM, Phan KL, Liberzon I, Abelson J, Klumpp H, Horwitz A, Mooney A, Raglan GB, Zalta AK. A 4-week morning light treatment reduces amygdala reactivity and clinical symptoms in adults with traumatic stress. Psychiatry Res. 2024 Dec;342:116209. doi: 10.1016/j.psychres.2024.116209. Epub 2024 Sep 21.

Reference Type RESULT
PMID: 39316998 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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1R61MH117157-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00161267

Identifier Type: -

Identifier Source: org_study_id